BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 3354234 · Received September 18, 2013

    Report

    Report Number
    2245578-2013-00097
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 21, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN ABBOTT POINT OF CARE (APOC) CUSTOMER REPORTED ACT KAOLIN CARTRIDGES THAT YIELDED 3 QUALITY CHECK CODE (QCC) 23'S, 3 QCC 39'S AND 1QCC 22 ON 08/14/2013, ALL WITH THE SAME PATIENT RECEIVING HEPARIN THE CATH LAB. THERE WAS NO OTHER PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. ON (B)(6) 2013 THE SITE REPORTED THAT THE PATIENT WAS SUSPECTED OF HAVING AN ABDOMINAL AORTIC ANEURYSM (AAA). AN INTERVENTION WAS RUN TO VERIFY AND DETERMINE THE SEVERITY OF THE AAA AND BASED ON THE FINDINGS, THE PATIENT WAS ADMITTED. BASED ON THE INFORMATION AVAILABLE THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THERE IS NO REASON TO BELIEVE THAT A MALFUNCTION EXISTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469959 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE NA T13098

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male